Rivaroxaban, the active ingredient in Xarelto, works by inhibiting factor X, an enzyme that facilitates the blood coagulation process. One of the big advantages of direct factor X inhibitors is that they work very quickly, but this is also one of the more serious Xarelto side effects. Other blood-thinners like warfarin take longer to work because they indirectly affect the blood-clotting process.
However, unlike warfarin, there is no antidote to reverse the effects of rivaroxaban and similar drugs. This means that patients who are severely injured while taking Xarelto have a high risk of bleeding to death, since their blood will not clot. These problems have led to a number of lawsuits against the makers of Xarelto – Janssen, a Johnson & Johnson subsidiary.
Xarelto Safety Concerns
There are a number of safety concerns related to Xarelto, from mild side effects to more serious conditions.
Xarelto and Bleeding
The biggest side effect of taking an anticoagulant drug like Xarelto is severe bleeding. When taking a blood-thinning drug, minor cuts can become dangerous and even life threatening, because it takes so long for bleeding to stop. It may also be easier to bruise while taking the Xarelto.
Unfortunately, unlike some other blood-thinners like warfarin, rivaroxaban and other factor Xa inhibitors do not have an “antidote” to stop the effects of the drug. With warfarin, it is possible to reverse the anticoagulant effect by taking vitamin K. However, with Xarelto, there is no treatment available to stop the effects of the drug, which can lead to serious health risks.
In 2016, one potential antidote for Xarelto – a drug called Andexxa developed by Portola Pharmaceuticals – was rejected by the U.S. Food & Drug Administration. Although Portola claims that the drug is effective at reversing the anticoagulant effects of factor Xa inhibitors, based on two studies published in The New England Journal of Medicine, the FDA wanted to know more about the drug’s manufacturing process and labeling information before providing its approval.
Xarelto can cause adverse effects due to interactions with certain drugs, vitamins, and supplements. Many of the drugs that can have adverse effects include other drugs that have blood-thinning effects, such as aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
The drug’s medication guidelines warn patients to tell their doctors if they are taking any of the following medications or supplements in addition to Xarelto.
Approved Uses of Xarelto
|Common Dosages||10 mg, 15 mg, 20 mg|
|FDA Approval||Approved in July 2011; label updated in August 2016|
In 2011, Xarelto was approved by the U.S. Food & Drug Administration (FDA) to prevent venous thromboembolism (VTE) – that is, blood clots – specifically after knee or hip replacement surgery. Lower-body joint surgeries are especially prone to developing blood clots during recovery, which can lead to health problems like stroke or even death.
Since the original approval, Xarelto has also been approved to treat two other conditions. Foremost, it can be used to reduce the risk of systemic embolism (traveling blood clots) and stroke in individuals who have been diagnosed with nonvalvular atrial fibrillation, a form of cardiac arrhythmia.
The final approved use is the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). Deep vein thrombosis typically occurs in the large veins of the legs, and can develop especially after surgery or in people who lead sedentary lifestyles. Certain medical conditions and diseases can also increase the risk of developing DVT. If the thrombosis (blood clot) gets big enough, it can break off and travel through the body, often getting caught in the lungs, where it becomes a pulmonary embolism. Pulmonary embolisms are serious medical conditions that can lead to trouble breathing, chest pain, and even death if left untreated.